Device, system and method for pericardial access

Abstract

Device for accessing a pericardial space of a subject in need thereof, the device including a tubular member having an atraumatic distal end and a thread formed on, and at least partially around, the outer surface of the tubular member, proximally to the distal end; wherein the thread is configured to cut, puncture and/or penetrate a pericardium.

The invention claimed is: 
     
       1. A device for accessing a pericardial space of a subject in need thereof, the device comprising:
 a tubular member having an open ended atraumatic distal end, a proximal end, and a wall having an outer surface and an inner surface forming a lumen, wherein the tubular member and the atraumatic distal end are not movable with respect to each other; 
 a thread formed on, and at least partially around, said outer surface, proximal to said atraumatic distal end, wherein said thread ends at a sharp distal tip spaced at a constant distance of between 2 and 10 mm, inclusive, from the atraumatic distal end, 
 a first bio-impedance sensor positioned on the atraumatic distal end; and 
 a second bio-impedance sensor positioned on a distal end of the thread; 
 wherein said thread is configured to cut, puncture and/or penetrate a pericardium, when in use, at an essentially perpendicular and/or tangential angle relative to said longitudinal axis of said tubular member, and 
 wherein the atraumatic distal end is configured to protect said subject's heart and/or myocardium from being damaged. 
 
     
     
       2. The device according to  claim 1 , wherein the proximal end of said tubular member comprises an attachment mechanism configured to reversibly attach said tubular member to a handle. 
     
     
       3. The device according to  claim 2 , wherein the proximal end of said tubular member comprises a securing element configured to ensure proper connection of said tubular member to said handle. 
     
     
       4. The device according to  claim 1 , wherein said tubular member is open ended, thereby enabling passing a medical instrument and/or medicament through said lumen into said pericardial space, when said device has penetrated into said pericardial space. 
     
     
       5. The device according to  claim 1 , wherein said tubular member comprises a penetrable end-cap covering the lumen opening; wherein said penetrable end-cap is penetrable from within said lumen, such that a medical instrument and/or medicament passed through said lumen can enter said pericardial space. 
     
     
       6. A method for accessing a pericardial space of a subject in need thereof, the method comprising:
 inserting the device of  claim 1  into a chest cavity; 
 advancing the device to the pericardium until said atraumatic distal end reaches and/or presses against said pericardium; and 
 rotating said tubular member along its longitudinal axis, such that said thread cuts, punctures and/or penetrates said pericardium, thereby allowing said tubular member's distal end to enter said pericardial space. 
 
     
     
       7. The method according to  claim 6 , further comprising moving said tubular member along its longitudinal and/or axial axis concurrently with the rotating thereof, thereby screwing said thread through and/or into said pericardium. 
     
     
       8. The method according to  claim 7 , further comprising rotating said tubular member without advancement, thereby lifting and/or separating layers of the pericardium. 
     
     
       9. The method according to  claim 8 , further comprising generating a workspace by rotating said tubular member without advancement, thereby lifting and/or separating layers of the pericardium. 
     
     
       10. The method according to  claim 9 , wherein the device further comprises one or more sensors configured to detect penetration of said device into said pericardial space and wherein the method further comprising obtaining a signal from the one or more sensors. 
     
     
       11. The method according to  claim 10 , wherein, when a signal indicative of penetration into said pericardial space is obtained, said rotation and/or longitudinal movement of said tubular member is halted. 
     
     
       12. The method according to  claim 11 , further comprising inserting a medical instrument through said tubular member's lumen into said pericardial space. 
     
     
       13. The method according to  claim 12 , further comprising delivering a medicament through said tubular member's lumen to said pericardial space.